Senior Director, Regulatory Writing & Strategy

Eli Lilly and Company; Indiana (PA); Remote; USD 190,000 - 240,000; Full time

Job summary

Lilly seeks a Senior Director to lead regulatory and medical writing within ExploR&D, guiding the creation of clinical and regulatory documents and IT tools to support projects across the portfolio.

You will manage processes, vendor relationships, and systems implementations, coordinating content across complex documents to ensure accuracy, compliance, and high-quality outputs for regulatory interactions and publications.

Qualifications

• Advanced degree (PharmD/PhD/MD) in health-related field.
• 7+ years in pharma with regulatory writing or related areas.
• Experience leading cross-functional teams.
• Experience with external partnerships/vendors.
• Strong English writing proficiency.
• Knowledge of GCP/GLP regulations.

Responsibilities

• Lead cross-functional teams to develop writing deliverables.
• Manage workload and resource capacity.
• Coordinate writing of complex regulatory documents and strategic plans.
• Oversee QA and finalization of documents.

Skills

Regulatory writing

Project management

Leadership

Cross-functional collaboration

Strategic planning

Regulatory affairs

AI writing capabilities

Vendor management

Education

Advanced degree in health-related field

Tools

Document management systems

AI writing tools

Automation tools

Job description

Lilly seeks a Senior Director to lead regulatory and medical writing within ExploR&D, guiding the creation of clinical and regulatory documents and IT tools to support projects across the portfolio.

You will manage processes, vendor relationships, and systems implementations, coordinating content across complex documents to ensure accuracy, compliance, and high-quality outputs for regulatory interactions and publications.